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Genome Wide Association Study Evaluating Genetic Factors Related to the Efficacy and Tolerability of Fludarabine Treatment in Patients With CLL


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Genome Wide Association Study Evaluating Genetic Factors Related to the Efficacy and Tolerability of Fludarabine Treatment in Patients With CLL


OBJECTIVES:

- To identify genetic characteristics associated with the efficacy and toxicity of
fludarabine-based treatment in patients with chronic lymphocytic leukemia who
participated on E2997.

- To validate these genetic characteristics with a cancer cell model system to confirm
association and dissect the mechanism of effect.

OUTLINE: Archived DNA samples are analyzed for genetic characteristics associated with the
efficacy and toxicity to fludarabine-based treatment using Affymetrix 6.0 single nucleotide
polymorphism arrays. The results are then compared with data of genes identified in a cancer
cell model system, and with clinical data (response, toxicity, overall survival, and
progression-free survival) associated with each patient sample.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of chronic lymphocytic leukemia

- Archived DNA samples

- Received fludarabine with versus without cyclophosphamide on clinical trial E2997

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Association of single SNP genotype with overall and progression-free survival

Safety Issue:

No

Principal Investigator

Tait D. Shanafelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

Unspecified

Study ID:

CDR0000674957

NCT ID:

NCT01145469

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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